Breast cancer drug Abraxane (nanoparticle albumin-bound paclitaxel) has been shown to extend overall survival (OS) for patients with metastatic pancreatic cancer when used in combination with current standard of care, gemcitabine, with some patients surviving longer than three years.
The updated OS data from the pivotal Phase 3 Metastatic Pancreatic Adenocarcinoma Clinical Trial (MPACT) of Abraxane in combination with gemcitabine was presented at the recent American Society of Clinical Oncology (ASCO) Gastrointestinal (GI) Conference in San Francisco by Australian oncologist Professor David Goldstein.
Goldstein, who is based at the Prince of Wales Hospital in New South Wales, said that the data was “extremely encouraging” and paved the way for Abraxane to be used as a first-line therapy in the treatment of pancreatic cancer.
“Importantly, this large multinational trial in metastatic pancreatic cancer has demonstrated important three year survival rates, with 4% of patients in the Abraxane plus gemcitabine arm alive after three years, compared to none in the gemcitabine alone arm, and a near 30% improvement in survival outcomes,” he said.
“This cancer is the fourth most common cancer in Australia for both men and women and typically patients diagnosed with metastatic pancreatic cancer have a median life expectancy of approximately three to six months. These patients have very limited treatment options as there have been no new medications approved for metastatic pancreatic cancer in nearly seven years.
Data from this important study shows that Abraxane, when used in conjunction with standard of care gemcitabine, can substantially improve OS, with predictable and manageable side effects.”
The MPACT study was conducted at a number of sites internationally, including 20 sites in Australia, and involved 861 patients, of which 120 were Australian.
The median survival benefit in the updated analysis was extended in the Abraxane plus gemcitabine arm with a 2.1 month OS improvement compared to gemcitabine alone. This compares favourably with the 1.8 months improvement previously reported in the New England Journal of Medicine.
Carlo Montagner, chief executive officer of Australian biopharmaceutical company, Specialized Therapeutics Australia (STA), said Abraxane is currently approved in the United States and Europe as a first-line therapy in combination with gemcitabine for patients with metastatic pancreatic cancer.
He said a submission to the Therapeutic Goods Administration (TGA) for the regulatory approval of Abraxane (in combination with gemcitabine) for first-line treatment of locally advanced unresectable or metastatic adenocarcinoma of the pancreas was made in 2013. An application for a Pharmaceutical Benefits Scheme (PBS) listing for this indication has also been submitted with the Pharmaceutical Benefits Advisory Committee (PBAC) and will be reviewed at the March 2014 meeting.
Mr Montagner commented: “We are extremely pleased with these results presented at the ASCO GI conference and look forward to a TGA approval for Abraxane and a subsequent PBS listing for Australian patients with this difficult to treat cancer.”
Abraxane is currently TGA approved for the treatment of metastatic breast cancer and first-line Non Small Cell Lung Cancer (NSCLC).
Date: January 18, 2014
Filed Under: Drug Discovery